Catalog Number 912082 |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was reported approximately three (3) weeks ago during surgery, the clear sleeve of the juggerknot did not move clearly or smoothly.The surgeon used another product to complete the surgery.Attempts have been made and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Visual examination of the returned product/provided pictures identified the device was returned because the sleeve wouldn¿t move smoothly.The sutures and anchor were not returned.The sleeve was fully pressed against the handle.The sleeve was function checked with the bone block per the functional testing of the juggerknot mini memo and is conforming.Item and lot numbers are not confirmed as they are not etched on the part.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.No device problem found; the returned products were conforming during functional check.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|